Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00206622
First received: September 12, 2005
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women


Condition Intervention Phase
Hot Flashes
Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)
Drug: Menostar (Estradiol transdermal)
Drug: Placebo transdermal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Lowest effective dose in decreasing the frequency and severity of hot flushes

Secondary Outcome Measures:
  • Other symptoms related to menopause

Enrollment: 425
Study Start Date: December 2004
Study Completion Date: February 2006
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Active Comparator: Arm 2 Drug: Menostar (Estradiol transdermal)
1mg 17 Beta-estradiol transdermal patch
Placebo Comparator: Arm 3 Drug: Placebo transdermal
Placebo

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Menopause
  • Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)

Exclusion Criteria:

  • Hormonal treatment
  • Contraindication to estrogen/progestogen therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206622

  Show 45 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00206622     History of Changes
Other Study ID Numbers: 91429, 308261
Study First Received: September 12, 2005
Last Updated: May 28, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on April 14, 2014